Status:
COMPLETED
Tonometry Precision and Accuracy During PROSE Scleral Lens Wear: A Pilot Study
Lead Sponsor:
Boston Sight
Conditions:
Intraocular Pressure and PROSE Lens
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this research is to determine the reproducibility of measurements of intraocular pressure (IOP) when a scleral lens is on the eye. The PROSE device (PD) is a specialized scleral lens that ...
Detailed Description
The goal of this research is to determine the reproducibility of measurements of intraocular pressure (IOP) when a scleral lens is on the eye. This is a prospective study of the reproducibility of th...
Eligibility Criteria
Inclusion
- Written Informed Consent has been obtained prior to any study-related procedures taking place
- Written documentation has been obtained in accordance with the relevant county and local privacy requirements, where applicable
- Male or female, 18 years of age and older prior to the initial visit
- Is an established wearer of PROSE in both eyes; without fenestrations or channels; with diameter equal to or greater than 18.0 mm
- Upon examination by the investigator, there is adequate exposure of the sclera as required for IOP measurements with the planned device
- In the opinion of the investigator, the subject has the ability to follow study instructions
- In the opinion of the investigator, the subject has the ability to complete all study procedures and visits
Exclusion
- Is aphakic (i.e., missing their natural lens inside the eye)
- Is currently participating in any other type of eye-related clinical or research study
- Is pregnant or nursing as reported by the subject
- Less than 18 years of age
- Has a condition or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound study outcomes, or may significantly interfere with the subject's participation in the study
- Has had previous ocular surgery within the past 12 weeks
- Has a diagnosis of glaucoma, glaucoma suspect, ocular hypertension or prior glaucoma surgery
Key Trial Info
Start Date :
April 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04308941
Start Date
April 13 2020
End Date
April 27 2021
Last Update
November 9 2023
Active Locations (1)
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1
BostonSight
Needham, Massachusetts, United States, 02494